The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0519-2023·Announced 2023-04-12

Rosuvastatin Calcium Tablets Recalled for Manufacturing Deviations

Preferred Pharmaceuticals, Inc. is recalling Rosuvastatin Calcium 10 mg tablets nationwide due to cGMP deviations identified during FDA inspection of the manufacturing facility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for manufacturing process deviations with no reported illnesses, injuries, or hospitalizations. The hazard is compliance-related rather than a confirmed product defect.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Rosuvastatin Calcium Tablets, USP, 10 mg, due to current Good Manufacturing Practice (cGMP) deviations identified at the manufacturing facility, Accord Healthcare, Inc. The recall affects products distributed nationwide in the United States.

The affected products include 30-count and 90-count bottles with specific lot numbers: F2022N, F0322I, J1322H, K0222N, L2322D, and L2822J, with expiration dates ranging from August 2023 to July 2025. Product NDCs are 68788-7086-3 and 68788-7086-9.

The recalled product

Product
ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM)
Brand
ROSUVASTATIN CALCIUM
Manufacturer
Preferred Pharmaceuticals, Inc.
Category
Drug — Cardiovascular / Statin
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • a) Lot: F2022N
  • Exp. Date: 2/29/2024
  • b) Lot: F0322I
  • Exp. Date: 8/31/2023
  • Lot: J1322H
  • Lot: K0222N
  • Exp. Date: 6/30/2024
  • Lot: L2322D and Lot: L2822J
  • Exp. Date:7/31/2025.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by Preferred Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

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